Results from Breo Ellipta Clinical Trial in COPD Patients Presented by GSK

Results from Breo Ellipta Clinical Trial in COPD Patients Presented by GSK

GlaxoSmithKline recently presented new data from two analyses of the SUMMIT trial, a study that evaluated the impact of Breo Ellipta (fluticasone furoate/vilanterol or FF/VI 100/25 mcg) on the survival of patients with chronic obstructive pulmonary disease (COPD) with moderate airflow limitation and a history of increased risk of cardiovascular disease (CVD). Data on pneumonia events was also presented at the ATS 2016 International Conference May 13-18 in San Francisco.

The first analysis, “The impact of vilanterol, fluticasone furoate, or their combination on exacerbations in COPD patients with moderate airflow obstruction: the SUMMIT trial,” evaluated the impact of FF/VI 100/25 mcg on exacerbations in COPD patients with moderate airflow limitation [mean forced expiratory volume in one second, or FEV1, a measure of lung function, 60 percent predicted].

Results showed that patients who received FF/VI 100/25 mcg had a decrease of 20 percent in the risk of COPD exacerbation, compared to those who were treated with placebo. Additionally, the results showed that treatment with FF/VI 100/25 mcg reduced the rate of a moderate to severe exacerbation of COPD by 29 percent compared to placebo.

The second analysis, “Reported Pneumonia Events in the SUMMIT trial,” evaluated all reported pneumonia events among the 16,568 patients in the SUMMIT trial. The results revealed that rates were identical for patients who received FF/VI 100/25 mcg compared with those who received the placebo. Pneumonia related adverse events on FF/VI 100/25 mcg were 6 percent vs. placebo at 5 percent.

“We believe these data are important for COPD physicians and are clinically relevant,” said Dr. Courtney Crim, director of clinical development, R&D Respiratory at GSK, in a press release. “These findings from SUMMIT show that COPD patients with moderate airflow limitation experienced both a lower risk of having an exacerbation and fewer exacerbations when treated with FF/VI than patients on placebo.

“In the same patients with moderate airflow limitation, we also saw a similar incidence of pneumonia in patients on FF/VI and those on placebo. In previous studies in more severe patients, an increase in the incidence of pneumonias has been observed in ICS [inhaled corticosteroids]-containing treatment arms. The finding from this study is therefore interesting and will require further investigation,” Crim added.

Breo Ellipta inhalation powder contains a combination of fluticasone and vilanterol. Fluticasone is a steroid, and it prevents the release of substances in the body that cause inflammation. Vilanterol is a bronchodilator, and it works by relaxing muscles in the airways to improve breathing.

Breo Ellipta is a once-daily combination medicine used in adults with asthma or COPD to improve symptoms and prevent bronchospasm or asthma attacks.

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